Exam (elaborations)
ACRP CCRA Exam 2024!!
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ACRP CCRA Exam 2024!!
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Name: Score:15 Multiple choice questions
Definition 1 of 15
Guideline for good clinical practice - falls under the "efficacy" category. It pertains specifically to
the conduct of clinical research to support marketing applications for drugs
ICH E6
Ich E11
Ich E9
Ich E8
Term 2 of 15
Purpose of DSMB
To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints
To approve the trial protocol
The purpose of ich-gcp is to standardize the design, conduct, recording and reporting of
clinical trials.
To ensure accuracy of data and to carry out data analysis
Definition 3 of 15
Determine safety, side effects, best dose, and timing of treatments
Purpose of dsmb
The declaration of helsinki
The purpose of ich-gcp
Primary purpose of phase I trial
, Definition 4 of 15
The purpose of ICH-GCP is to standardize the design, conduct, recording and reporting of
clinical trials.
Purpose of dsmb
The purpose of ICH-GCP
Purpose of irb/iec
Primary purpose of phase i trial
Term 5 of 15
What does DSMB stand for?
Data Safety Monitoring Board
The Sponsor
To Protect Subject Safety
Ethics Committee
Definition 6 of 15
Legally Authorized Representatives
LUDI
YACER
APR
LAR
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